Disposable Surgical Mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 15, 2021 Heilongjiang Yinjia Medical Equipment Co., Ltd. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China Re: K212944 Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 2, 2021 Received: September 13, 2021 Dear Doris Dong: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212944 Device Name Disposable Surgical Mask Indications for Use (Describe) The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary [As required by 21 CFR 807.92] | 1. Submission Information: | | |------------------------------|----------------------------------------------------------------------------| | 510(k) Number: | K212944 | | Date: | December 15, 2021 | | Type of 510(k) Submission: | Traditional | | Basis for 510(k) Submission: | New device | | Applicant/Manufacturer: | Heilongjiang Yinjia Medical Equipment Co., Ltd. | | | F3-4, Plant 6, No.10, Hanan 12th Road, Nangang District, Harbin City | | | Heilongjiang, China 150000 | | Contact person: | Doris Dong | | | [Consultant, from Shanghai CV Technology Co., Ltd.] | | | Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | | | E-mail: doris.d@ceve.org.cn | | | Tel: 86 21-31261348 / Fax: 86 21-57712250 | #### 2. Device Description: | Proprietary Name: | Disposable Surgical Mas | |----------------------|-------------------------| | Model | Size M, Size S | | Common Name: | Surgical mask | | Classification Name: | Mask, Surgical | | Regulation Number: | 878.4040 | | Product Code: | FXX | | Device Class: | II | | Review Panel: | General Hospital | #### 3. Predicatedevice Surgical Face Mask, K182515 WUHAN DYMEX HEALTHCARE CO., LTD This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### 4. Device Description Disposable Surgical Mask, Ear Loop Type, Size M and S is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The latex free elastic ear loops are made of polyamide fibers and spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of core iron wire with halogen-free polyethylene covering. The Disposable Surgical Mask will be provided in blue of outside and white of inside. The Disposable Surgical Mask is provided non-sterile and for single use. {4}------------------------------------------------ #### 5. Intended Use/Indication for use The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. #### 6. Technological Characteristics Comparison with the predicate device: #### Table 1 General comparison | Device | Proposed device | Predicate device | Comparison | | |--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--| | 510(k) Holder | Heilongjiang Yinjia Medical<br>Equipment Co., LTD | WUHAN DYMEX<br>HEALTHCARE CO., LTD | -- | | | 510(k) Number | K212944 | K182515 | -- | | | Name | Disposable Surgical Mask | Surgical Face Mask | -- | | | Model | Size M, Size S | / | -- | | | Classification | Class II Device, FXX (21 CFR<br>878.4040) | Class II Device, FXX (21 CFR<br>878.4040) | Same | | | Intended use/<br>Indications<br>for Use | The Disposable Surgical Mask is<br>intended to be worn to protect<br>both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids and<br>particulate material. The<br>Disposable Surgical Mask is<br>intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and<br>body fluids. This is a single use,<br>disposable device(s), provided<br>non-sterile. | The Surgical Face Masks are<br>intended to be worn to protect<br>both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids<br>and particulate material. These<br>face masks are intended for use<br>in infection control practices to<br>reduce the potential exposure<br>to blood and body fluids. This<br>is a single use, disposable<br>device(s), providednon-sterile. | Same | | | Mask style | Flat Pleated | Flat Pleated | Same | | | Design | Ear loop | Ear loop | Same | | | Layers | Three | Three | Same | | | Dimension | Size M: 175*95mm<br>Size S: 140*95mm | 175*95mm | Similar<br>Note 1 | | | Color | Blue outside; white inside | Yellow | Different<br>Note 2 | | | Sterility | Non-sterile | Non-sterile | Same | | | Target population | Adults | Adults | Same | | | Use | Single use, disposable | Single use, disposable | Same | | | Anatomical site | Nose and mouth | Nose and mouth | Same | | | Technology | Self-suction filter mask | Self-suction filter mask | Same | | | Environment of<br>use | OTC | OTC | Same | | | Material | | | | | | Outer facing layer | Spunbond polypropylene | Spunbond polypropylene | Same | | | Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | | | Inner facing layer | Spunbond polypropylene | Spunbond polypropylene | Same | | | Ear loops | Polyamide fibers, Spandex | Spandex | Same Note 2 | | | Nose piece | Core iron wire with polyethylene<br>covering | Malleable polyethylene wire | | | | Colorants | Polypropylene (PP) master batch | Unknown | | | | ASTM F2100 | Level 2 | Level 2 | Same | | | Level | | | | | | Biocompatibility (limited contact (<24h) surface devices on intact skin) | | | | | | Cytotoxicity | Under the conditions of the<br>study, the proposed device<br>extract was determined to be<br>non-cytotoxic. | Under the conditions of the<br>study, the predicate device<br>extract was determined to be<br>non-cytotoxic. | Same | | | Irritation | Under the conditions of the<br>study, the proposed device non-<br>polar and polar extracts were<br>determined to be<br>non-irritating. | Under the conditions of the<br>study, the predicate device<br>non-polar and polar extracts<br>were determined to be<br>non-irritating. | Same | | | Sensitization | Under the conditions of the<br>study, the proposed device non-<br>polar and polar extracts were<br>determined to be<br>non-sensitizing. | Under the conditions of the<br>study, the predicate device<br>non-polar and polar extracts<br>were determined to be<br>non-sensitizing. | Same | | {5}------------------------------------------------ Differences between New device and Predicate Device: #### Note 1: The proposed device has two sizes while the predicate device only has one size. Because the physical performance tests and Biocompatibility tests results of mask depend on the materials and manufacturing process not the size. Furthermore, there is no difference between the two models except for the size. #### Note 2: Biocompatibility evaluation has been performed on the finished device which includes all construction materials and color additives. {6}------------------------------------------------ #### 7. Non-clinical test performed on the proposed device: The proposed device was tested and conformed to the following standards and requirements stated in guidance for industry passed and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004: | Performance<br>Characteristics | Test Method | Proposed device | Acceptance Criteria | Result | |--------------------------------------|--------------|---------------------------------|---------------------------------|--------| | Fluid Resistance<br>Performance | ASTM F1862 | 31 out of 32 pass at<br>120mmHg | 29 out of 32 pass at<br>120mmHg | Pass | | Particulate Filtration<br>Efficiency | ASTM F2299 | 99.7% | ≥ 98% | Pass | | Bacterial Filtration<br>Efficiency | ASTM F2101 | 99.5% | ≥ 98% | Pass | | Differential Pressure<br>(Delta-P) | MIL-M-36954C | 4.24mmH2O/cm² | < 6.0mmH2O/cm² | Pass | | Flammability class | 16CFR 1610 | Class 1 | Class 1 | Pass | Table 2 Performance Testing #### 8. Clinical test conclusion No clinical study is included in this submission. #### 9. Conclusion The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated K182515.